Pharmacokinetics of Advantage Arrest
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Observed Fluoride Urinary Recovery
研究概览
简要总结
The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.
详细描述
The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC, and total urinary recovery) to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older, minimum 20 teeth, healthy, not taking prescription or OTC medications
排除标准
- •pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known sensitivity to silver or fluoride
研究组 & 干预措施
38% silver diamine fluoride
38% silver diamine fluoride, topical, 1 drop, single application
干预措施: 38% silver diamine fluoride (Drug)
结局指标
主要结局
Observed Fluoride Urinary Recovery
时间窗: baseline to 24 hours
24 hour fluoride urinary recovery (in mg)
Observed Silver Tmax
时间窗: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Observed silver time to maximum serum concentration in hours
Observed Silver Cmax
时间窗: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Observed silver maximum serum concentration in ng/mL
Observed Silver Baseline-Corrected Cmax
时间窗: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Observed silver baseline-corrected maximum serum concentration in ng/mL
Observed Silver t1/2
时间窗: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Observed silver serum elimination half-life in hours
Observed Silver 24 Hour Urinary Concentration
时间窗: baseline to 24 hours
Observed silver 24-hour urinary concentration in ng/mL
次要结局
未报告次要终点